QUALITY ASSURANCE ENGINEER, MEDICAL DEVICES
Job Overview
Serves as a core team member on software/firmware product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation (including unit and integration testing).
Chair the change control board within projects for change requests and defects identified during the course of development.
Provide valuable technical feedback in code reviews.
Lead (technical expert) and oversee/approve investigations of software/firmware related complaints, defects identified during development, or from manufacturing nonconformities, audit responses and CAPAs to identify root cause and corrective actions in a timely manner.
Generates, maintains and updates risk management documentation throughout the life cycle of a product.
Ensures compliance with software / firmware development and non-product software validation procedures.
Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert.
Knowledge, Skills and Abilities Required
Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304.
Develop and maintain strong, positive business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities, support audits / inspections, and develop and implement plans that will ensure company compliance with regulatory requirements.
Collaborate with other areas within Quality to achieve quality objectives.
Exhibit strong leadership skills showing ability to influence both peers and other team members.
Exhibit Excellent written and verbal communication skills.
Demonstrate an ability to prioritize and plan activities.
Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of all company-wide functions meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements
Join us in our mission to deliver exceptional software products that meet the highest quality standards. We look forward to your application!
Job Type: Full-time
Pay: $120,000.00 - $140,000.00 per year
Benefits:
• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance
Compensation Package:
• Bonus opportunities
• Performance bonus
Schedule:
• 8 hour shift
• Day shift
Work Location: Remote
Apply Now
Serves as a core team member on software/firmware product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation (including unit and integration testing).
Chair the change control board within projects for change requests and defects identified during the course of development.
Provide valuable technical feedback in code reviews.
Lead (technical expert) and oversee/approve investigations of software/firmware related complaints, defects identified during development, or from manufacturing nonconformities, audit responses and CAPAs to identify root cause and corrective actions in a timely manner.
Generates, maintains and updates risk management documentation throughout the life cycle of a product.
Ensures compliance with software / firmware development and non-product software validation procedures.
Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert.
Knowledge, Skills and Abilities Required
Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304.
Develop and maintain strong, positive business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities, support audits / inspections, and develop and implement plans that will ensure company compliance with regulatory requirements.
Collaborate with other areas within Quality to achieve quality objectives.
Exhibit strong leadership skills showing ability to influence both peers and other team members.
Exhibit Excellent written and verbal communication skills.
Demonstrate an ability to prioritize and plan activities.
Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of all company-wide functions meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements
Join us in our mission to deliver exceptional software products that meet the highest quality standards. We look forward to your application!
Job Type: Full-time
Pay: $120,000.00 - $140,000.00 per year
Benefits:
• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance
Compensation Package:
• Bonus opportunities
• Performance bonus
Schedule:
• 8 hour shift
• Day shift
Work Location: Remote
Apply Now